Lead Clinical Data Manager

TITLE:

Lead Clinical Data Manager

Title: Lead Clinical Data Manager

Reports To: VP Clinical & Data Sciences

Location: Remote US

Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 500 individuals globally. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/Indivior.

POSITION SUMMARY:

The Lead Clinical Data Manager is responsible for all Clinical Data Management activities for Indivior: developing and implementing DM procedures and standards, managing DM vendors, systems and resources, overseeing data management activities, identifying most efficient sourcing model, future technology strategies to support Indivior clinical programs/submissions and ensure accurate, complete data acquisition, and integration.

ESSENTIAL FUNCTIONS:

The responsibilities of this role include, but are not limited to, the following:

• Develop, communicate and execute the data management vision and strategy, including optimum sourcing model, and clinical data acquisition/integration/reporting strategy
• Coordinate DM budget and resource needs
• Oversee/lead review of Data Management activities/outputs (vendor selection and oversight, eCRF development, EDC build, Edit Checks, UAT, Data collection/cleaning, data review, SDTM/CDASH development, DB lock) to ensure clinical programs are executed and reported within agreed upon timelines, budget and quality standards.
• Oversee reconciliation of external data sources.
• Partner with Pharmacovigilance colleagues to perform reconciliation of serious adverse events and other trial-specific events, as required.
• Lead the development and roll out of DM related SOP and Standards (eCRF, Edit Checks, etc)
• Collaborate and ensure DM vendor and contractors successfully collaborate with other functional areas to manage DM activities in order to meet the company goals and clinical program objectives
• Serve as Data Management representative at trial specific meetings and as primary contact for data management vendors, utilizing key performance indicators, metrics, and timelines to assess vendor quality and performance. Escalate issues as needed.
• Understand and stay abreast of Industry Standards in Data Management (data acquisition, integration, review, documentation)
• Demonstrate knowledge of the regulatory requirements as they relate to Data Management, including Data Management systems and data reporting (i.e. CDISC/CDASH)
• Train, coach and oversee external staff – Ensure staff complies with company policies/SOPs and external regulations

MINIMUM QUALIFICATIONS:

• Master/Bachelor degree of Science with at least 7 years (10 years preferable) of experience in pharmaceutical or biotech industry
• Advanced knowledge in all aspect of Clinical Data Management, industry standards and practices in clinical data management, databases, including 21CFR part 11, 21CFR part 812, ISO 14155 and CDISC/CDASH standards
• Advanced knowledge of Data Management systems (OC-RDC Medidata Rave is a plus), and Centralized/ Risk Based Monitoring
• Knowledge of medical